Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (

Components of Participating Organizations
National Institute of Mental Health (NIMH) (

Title: Clinical Research on Mental Illnesses in Older Adults (R01)

Announcement Type
This is a reissue of PA-03-014, which was previously issued on October 22, 2002.

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using For more information and an initial timeline, see NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( Specific funding opportunity announcements will also clearly indicate if submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-06-422

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release Date: May 17, 2006
Application Submission Date(s): Standard dates apply, please see for details.AIDS Application Receipt Dates(s): Not applicable.
Peer Review Date(s):See
Council Review Date(s):See
Earliest Anticipated Start Date(s): See
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives


The National Institute of Mental Health (NIMH) invites grant applications for clinical research that will reduce the burden of mental illnesses on older adults. NIMH has a long-standing commitment to geriatric mental health research, which is supported by several components of the Institute. The greatest concentration of clinical studies of mental illnesses in older individuals, which is the focus of this announcement, is based programmatically in the Geriatrics Research Branch. With a review of the Branch’s late-life research portfolio, NIMH has identified opportunities for enhancing and strengthening its investment in late-life research. The intent of this Funding Opportunity Announcement is to intensify investigator-initiated research in this area, to attract new investigators to the field, and to enhance interdisciplinary approaches to research.



The United States has a larger number of older adults than at any other time in its history, and this number is rapidly increasing. As of July 2003, U.S. Census estimates project that 35.9 million Americans are 65 years of age or older, comprising 12.3 percent of the population. By 2030, the number of older adults will have increased to over 71.5 million doubling the current size of this age group and making older adults roughly 20 percent of the U.S. population. This rapid increase in our aging adult cohort creates an increased need to understand and reduce the public health burden of mental illnesses on older Americans.

Through its Geriatrics Research Branch, NIMH supports a broad portfolio of clinical research relating to major mental disorders in late life , which includes studies of the phenotypic characterization and risk factors for these disorders; studies to elucidate their etiology, psychopathology, and pathophysiology; and development and evaluation of both assessment methods and psychosocial, psychopharmacologic, and somatic interventions to treat or prevent disorders. Disorders of interest include: mood, anxiety, and personality disorders; psychotic disorders and schizophrenia; Alzheimer’s disease and related dementias; suicide; neuroregulatory disorders and homeostatic disorders including sleep disorders, eating disorders, and disorders associated with the menstrual cycle. .Although old age or later life are conventionally identified with persons 65 years or older, studies involving participants outside that exclusive age range may be classified as geriatric research on other bases, as well. Thus, the Geriatrics Research Branch supports clinical studies with mixed or comparative age samples in which there is a preponderance of geriatric participants or a central emphasis on questions relating to aging or developmental processes in late life, as well as research that has other special relevance to mental disorders among older adults (including animal studies that attempt to model specific clinical features of these disorders). Based on a recent review of this Branch’s portfolio, NIMH has identified opportunities for enhancing and strengthening its support for late-life clinical research. As noted below, additional types of aging-related research, including geriatric mental health services research, are supported by other NIMH programs and Divisions and in other Institutes and Centers.

Areas of Opportunity

Within the Geriatrics Research Branch programs, NIMH has particular interest in expanding translational research aimed at understanding the etiology and pathophysiology of mental illness in late life, identifying risk and protective factors and their relationship to the development of various disorders, and hastening the translation of behavioral science and neuroscience advances into innovations in clinical care. Opportunities exist to develop novel models of late-life mental disorders and to develop and validate endophenotypes and biomarkers for various aspects of these conditions, In particular, a significant number of opportunities are available to integrate findings and newly developed techniques from neuroimaging studies and genetics research into late-life clinical research.

NIMH encourages intervention research across the spectrum from new treatment development efforts to effectiveness outcome studies examining optimal utilization of existing mental health interventions to benefit older adults with mental disorders. Such intervention research may include both psychosocial and pharmacological approaches and their combinations, and prevention as well as treatment studies. Significant opportunities exist to identify predictors of older adults response to varying interventions, including vulnerability to side effects, and to develop markers that will aid understanding of treatment mechanisms and processes of change in this age group.

To these ends, NIMH encourages applications proposing multidisciplinary research programs involving both clinical investigators and collaborators from molecular neuroscience, cognitive sciences, and social and behavioral sciences so as to facilitate the translation of basic science and preclinical research to clinical research. Such studies may examine basic findings from various sciences for their relevance in understanding late-life mental disorders and/or in developing new and improved assessments and treatments for these disorders, utilizing such techniques as brain imaging, pharmacogenetics and genomics, and the methods of molecular biology, cognitive neuroscience, neuropsychology, and the behavioral and social sciences.

Virtually every area studied by NIMH-funded researchers has opportunities for expansion. The following section describes some of these areas that are of particular interest, but is not meant to be all-inclusive.

a. Relationships of Late-life Mood and Anxiety Disorders to Cognitive Impairment, Central Nervous System Pathology, and Mortality

Cognitive impairment is often observed in depressed older adults, and a growing body of evidence suggests that late-life depression is associated with increased risks of cognitive decline and/or progression to frank dementia over time. Likewise, many depressed older adults suffer from other coexisting medical illnesses, and numerous studies have linked depression with poorer outcomes of treatments for these illnesses and with increased mortality risks. The biological and/or behavioral processes and mechanisms underlying these patterns have not been well studied and are poorly understood, Whereas some studies suggest that chronic experience of depression may lead to developing particular forms of neuropathology, others suggest that depressive syndromes in older adults may often occur simply as a prodromal phase or manifestation in the gradual progression of degenerative dementias, such as Alzheimer’s disease or cerebrovascular forms of dementia. Symptoms of depressed mood and anxiety frequently coexist in older adults, and the admixture is predictive of attenuated response to treatments for depression. However, relationships between anxiety disorders and cognitive impairments and mortality have not been extensively studied. Advances in neuroimaging and cognitive neuroscience have created new opportunities to utilize basic science methods to better delineate the cognitive dysfunction that frequently accompanies late life depression, and that appears to moderate and predict response to antidepressant treatments, and to identify the associated patterns of neuropathology or other mechanisms linking late-life affective disturbance with increased cognitive and mortality risks. Examples of studies that might be proposed to examine pertinent questions in this general area include:

b. Safety Issues in Antipsychotic Treatment of Older Adults

A growing body of evidence indicates that treatment with antipsychotic medications may place older adults at an increased risk of developing strokes, metabolic syndromes, or other adverse physiological effects, including falls and fractures. Increased mortality rates appear to apply to older adults treated with conventional neuroleptic as well as the newer atypical antipsychotic medications. The existing findings led the Food and Drug Administration to issue a warning in 2005 about the risks of treating older adults with dementia with the atypical antipsychotics. In the current context, both clinicians and older individuals themselves and their families lack adequate information to make well reasoned decisions about treatment options for such clinical problems as agitation and psychosis in older adults with dementia, and maintenance treatment of older adults with chronic schizophrenia. A broad range of studies is urgently needed to identify the mechanisms underlying the long-term adverse effects of antipsychotic treatments in older adults, the particular neurobiological or clinical characteristics predictive of vulnerability to these effects, and relative benefits and risks of various antipsychotic treatment options. Examples of studies that might be usefully pursued include:

c. Accuracy and Efficiency of Assessment and Diagnostic Methods for Late-life Mental Disorder

Older adults with symptoms of mental disorder often do not fit the typical profiles or standard categories specified by diagnostic nomenclatures. They may have the same symptoms at lower severity or different duration than stated in diagnostic criteria, or their symptom pattern may be different. It may be difficult to ascertain or interpret their symptoms because they may have other co-occurring physical or mental illnesses. Ultimately, to reduce the burden of mental illnesses on these individuals, it is necessary to have valid conceptualizations of those illnesses that are in fact typical in late life, as well as assessment methods known to be valid for use with older adults. Examples of studies that might usefully address such research questions include:

d. Mental Health Diagnosis and Treatment of Racial/Ethnic Minority Elders

A major goal of NIMH research efforts with respect to late-life mental disorders is to expand the knowledge base about interventions that effectively reduce the burden that mental illnesses have on older Americans, their families, and society at large. As minority individuals have not been adequately represented in much past research, currently insufficient information is available about the accuracy and sensitivity of many mental health assessment methods for older adults from ethnic and racial minority groups, and about the relative efficacy and effectiveness of standard treatment approaches in various groups of minority elders. Studies dedicated to redressing these shortages of clinically relevant diagnostic and treatment data are needed. Examples of studies that might usefully be pursued in this area include:

e. Mental Health Intervention Packages/Algorithms Tailored to Diverse Geriatric Care Settings and Needs

A major goal of NIMH geriatric intervention research is to build knowledge about how mental health interventions with established efficacy can be effectively implemented and made accessible to a larger number of older adults who need them. This includes the development of treatment variants that can be efficiently employed in care settings where large numbers of older adults with mental disorders are typically seen, as well as algorithms for utilizing particular interventions appropriately in the various care contexts and at different steps or stages within the overall treatment process. Such research efforts may lead to development of more cost-effective ways of intervening that will enable delivery of treatment to more of those in need. Examples of studies that might usefully be pursued in this area include:

Services research addressing the mental health service needs of older adults is supported within all programs of the NIMH Services Research and Clinical Epidemiology Branch (see

The National Institute on Aging

The National Institute on Aging (NIA) also supports late-life research, including studies of the aging process, age-related diseases (including neuro-degenerative diseases), and special problems of the aging population (including disability). This Funding Opportunity in particular is targeted to mental illness research in late life and not the above-mentioned areas. Applicants should consider contacting program staff at NIMH or NIA for assistance in determining the Institute most appropriate for them.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this FOA may not exceed 5 years.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Cost sharing is not required. The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria

Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Application Submission Date(s): Standard dates apply. See
Peer Review Date(s): See
Council Review Date(s): See
Earliest Anticipated Start Date(s): See

3.A.1 Letter of Intent

A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at:

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement (

Pre-Award Costs are allowable. A grantee may, at his/her own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement and Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the signing official shown on the electronic application.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

George T. Niederehe, Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7220, MSC 9634
Bethesda, MD 20892-9634
Telephone: (301) 443-1369
FAX: (301) 443-1424

2. Peer Review Contacts:


3. Financial or Grants Management Contacts:

Rebecca Claycamp, M.S., CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122 MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:

Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. Even in geriatric research, inclusion of younger subjects may at times be appropriate for comparison or control purposes. Though it may often be acceptable not to include children in studies focused on disorders of late life, whenever this is the case it is incumbent on applicants to articulate the scientific or ethical bases for this exclusion.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at and view the Policy or other Resources and Tools including the Authors' Manual (

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

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